BioFlo 46610Recalls & reported problems
Navilyst Medical, Inc. · BioFlo Midline with ENDEXO Technology MST-45 Kit · Class 2
All models of BioFlo (87)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965466100), received between Apr 29, 2024 and Apr 29, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2024Fracture; Fracture
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A GUIDEWIRE FROM A BIOFLO MIDLINE 4F SL-20CM MST-45 KIT W/ TWO NITINOL GUIDEWIRES. A PIECE OF THE GUIDEWIRE BROKEN OFF INTO THE PATIENT AND WAS RETRIEVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 19201828 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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